Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott Products
• Treatments: Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• Children younger than four years with confirmed cystic fibrosis diagnosis and a body weight of at least 2 kilograms

Exclusion Criteria:

• Ileus or acute abdomen

• history of fibrosing colonopathy

• history of distal ileal obstruction without surgery

• solid organ transplant or surgery affecting the large bowel, other than appendectomy